US FDA Remote Regulatory Assessments (RRAs): Alturas Direct Experience and Differences between 2020 Remote Audit and 2022 Remote Record Review (RRR), Case Studies, Lesson Learned from the RRR Process, Suggestions on Best...
About the Presenter
With over 20 years in Quality Assurance, David Schumacher, RQAP-GLP since 2004, oversees the Alturas Analytics Quality Assurance Program. David is an experienced Quality Assurance Professional in FDA...
When developing a quantitative LC-MS/MS method, ideally the standard curve and quality controls should be prepared in a matrix as similar as possible to the study samples to limit the potential for dissimilar matrix components...
Determination of protein binding levels and free circulating drug in biological systems is important in establishing pharmacokinetic activity. The portion of drug that binds to protein within the body is rendered inactive and...
Microsampling enables increased sampling frequency for animal and human studies and decreases barriers to clinical trial enrollment. These benefits lead to larger and more inclusive datasets, but bioanalysis of microsamples...
Investigators have shown that one enantiomer of hydroxyglutarate (D-2-HG) is abnormally accumulated in a variety of human cancers, such as glioblastoma, acute myeloid leukemia and cholangiocarcinoma. The isocitrate...
